Liquid pharmaceutical composition comprising pegylated human erythropoietin, process for its preparation, medicament for the treatment of diseases correlated with anemia in chronic renal failure patients and device comprising such composition

摘要

The present invention relates to a liquid pharmaceutical composition comprising a pegylated human erythropoietin protein, a multiple charged inorganic anion being represented by sulfate anion, in a pharmaceutically acceptable buffer suitable to keep the solution pH in the range from about 5.5 to about 7.0, and optionally one or more pharmaceutically acceptable excipients wherein the composition is stable at room temperature. The invention also relates to a process for preparing the above-indicated composition, comprising mixing a pegylated human erythropoietin protein with a solution comprising a multiple, negatively charged anion being represented by sulfate anion, and optionally one or more pharmaceutically acceptable excipients in a pharmaceutically acceptable buffer suitable to keep the solution pH in the range from about 5.5 to about 7.0. The invention also discloses the use of the above-described composition for the preparation of medicaments useful for the treatment and prevention of diseases correlated with anemia in chronic renal failure patients (CRF), AIDS and/or for the treatment of cancer patients undergoing chemotherapy, and a device for local or systemic sustained release comprising the above-indicated composition and consisting of an implant, a syringe and an inhaler.